GS1 Standards for Medical Device Identification Global UDI AIDC Harmonization & GS1 Standards

Transcription

1 GS1 Standards for Medical Device Identification Global UDI AIDC Harmonization & GS1 Standards Global GS1 Healthcare Conference 2018 Bogotá, Colombia Tuesday - 10 April 2018

2 Global UDI AIDC Harmonization & GS1 Our Panel: Mark Hoyle (Session Chair) Technical Director, UDI - Teleflex Jackie Elkin Global Process Owner - Standard Product Identification - Medtronic Tom Jones Unique Device Identification (UDI) Program Director - Johnson & Johnson Volker Zeinar Global Coordinator Auto-ID Affairs - B. Braun GS

3 Mark Hoyle Technical Director, UDI Teleflex GS

4 Global Harmonization and GS1 Standards for Medical Device Identification GS1 Healthcare Conference, Bogota, Colombia. Mark Hoyle 4

5 Today s Presentations Global UDI Regulation Harmonisation Benefits & Risks Technical Challenges 5

6 UDI Unique Device Identification What is UDI? 6

7 The UDI Barcode What s on the Label? GS1-128 GS1 Data Matrix Machine Readable Human Readable The UDI Barcode contains various degrees of product data, Harmonising the requirement: (01) GTIN-Global Trade Item No. (11) Production Date (YYMMDD) (17) Expiration Date (YYMMDD) (10) Batch/Lot (21) Serial Number 7

8 UDI Data Sharing What is the Ask? Populate a National Database Share with Customers Share What? A Common Set of Data Attributes 8

9 UDI Labeling & UDI Data Sharing Ease of Implementation and Early Adoption is Enabled by Global Harmonisation 9

10 Why are there different barcode symbologies? Why GS1? Do GTINs Change on a Product? Can you share UDI information electronically? Where can I go to get more UDI information? 10 We Like Questions! Are you scratching your head? PLEASE Ask..

11 Thank You Mark Hoyle, Technical Director Global UDI Implementation 11

12 Jackie Elkin Global Process Owner - Standard Product Identification Medtronic GS

13 Global UDI Regulations Developments, directions, differences, GS1 as a global Issuing Agency Global UDI Regulations Developments & Differences GS1 as a Global Issuing Agency UDI GS1 Global Conference Bogota, Colombia April 11, 2018 JACKIE RAE ELKIN MEDTRONIC GLOBAL REGULATORY AFFAIRS

14 PRESENTATION SCOPE UDI Published Rules Focus on Aligned AIDC Rules Comparison of UDI Requirements in Publications Draft UDI Rules and Announcements Non-UDI Healthcare Ministry Implementations with a focus on GS1 14 Medtronic Confidential

15 UNIQUE DEVICE IDENTIFICATION Unique Device Identifier (UDI): An identifier that unambiguously identifies a device through its distribution and use. Comprised of Two Parts: 1. A Device Identifier (DI): a mandatory, fixed portion of a UDI that identifies the specific Product Number of a device and the labeler of that device; for Medtronic products, this is the GS1 Global Trade Item Number (GTIN); and 2. A Production Identifier (PI): a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of the device: The lot or batch within which a device was manufactured; The serial number of a specific device; The expiration date of a specific device; The date a specific device was manufactured; For an HCT/P regulated as a device, the distinct identification code required aka Donor Code. 15 Medtronic Confidential

16 UNIQUE DEVICE IDENTIFICATION REGULATION CONCEPTS 1 Development of a standardized syste m of Unique Device Identifiers(UDI) Combination of 3 Distinct Concepts 2 Placing UDI in Human Readable and AutoID Formats on Package, Label or on the Device 3 Register UDI Data in a Public Database GUDID (US) EUDAMED (EU) 16 Medtronic Confidential

17 Choose an Issuing Agency to develop the UDI and assign the Device Identifier. 17 Medtronic Confidential

18 Marking of UDI in human readable and auto-identification formats on product package, label or device. AIDC technology requirements (linear bar code, 2D bar code, RFID) will remain technology neutral and based on ISO standards. Must be adequate to identify the device through distribution and use. (01) (17) (10) 1234AB (01) (17) (10) 1234AB Questions to Consider: Is package label space an issue? Can all supply chain stakeholders read it? What type of auto-identification is appropriate for your application? 18 Medtronic Confidential

19 THE WORLD VIEW OF UDI

20 INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) UDI WORK GROUP UDI WG Established under Global Harmonization Task Force (GHTF) October, IMDRF Guidance UDI for Medical Devices Final Version, December 9, Medtronic Confidential

21 IMDRF UNIQUE DEVICE IDENTIFICATION APPLICATION GUIDE New Work Item Proposal (NWIP) for Harmonized UDI Application Guide presented to IMDRF Management Committee (MC) - March 2017 IMDRF MC instructed GMTA to prepare first draft of IMDRF UDI Application Guide. Draft submitted to IMDRF - July 7, 2017 IMDRF MC Approved NWIP (w/ revisions), Harmonized Unique Device Identifier Application Guide. - September 2017 IMDRF UDI WG kick-off - December 2017 Draft for Public Consultation - May

22 DIFFERENCES BETWEEN IMDRF, US FDA & EU MDR ADAPT EXISTING STRATEGIES AND SYSTEMS

23 REQUIREMENT IMDRF US EU PI of UDI not required Only applies to retail POS devices Applies to Class I devices Only applies to retail POS devices Manufacturing Date PI exception provided UDI required on label of Unit of Use (individual packaged units w/in a multipack) Unless it is the only PI on the label Unless it is the only PI on the label Unless it is the only PI on the label Excludes Class A & B Only required for implants Excludes Class I & IIa Labeling exception when constraints limiting both AIDC and HRI on Label AIDC format shall be favored No exception Only AIDC required Use of RFID as AIDC Also requires 2D bar code on label No requirement Also requires 2D bar code on label 23 Medtronic Confidential

24 IMDRF / US FDA / EU COMM COMPARISON REQUIREMENT IMDRF US EU UDI Carrier Readily identifiable AIDC must be evident or disclose its presence Readily identifiable Software as a Medical Device (SaMD) - Version Software Version included in the PI Software Version included in the PI Software Version included in the PI Human Readable Format of UDI GS1 Include AIs HRI format following the issuing agency /entity HRI format following the issuing agency /entity HRI format following the issuing agency /entity Mechanism for evaluating and adjudicating requests for UDI exemptions and alternative placement of UDI Provides for process to be included Extensive processes developed Does not provide Direct Marking Scope Devices that are reusable and require reprocessing between patients Devices that are reusable and require reprocessing between patients All devices that are reusable 24 Medtronic Confidential

25 IMDRF / US FDA / EU COMM COMPARISON REQUIREMENT IMDRF US EU The Direct Mark Format Data Carrier requires Allows AIDC or HRI or both AIDC and HRI both AIDC and HRI Direct Mark UDI Content Not addressed Identical to UDI on the label of the device, or Different UDI used to distinguish unpackaged device from package containing the device Direct Marking Exceptions Not possible due to size, Interfere with the safety design, materials, or effectiveness; processing, or Not technologically performance issues feasible; Device is a single-use; Device has been previously marked Direct Marking Compliance Timelines Two years after label compliance date w/udi Two years after label compliance date Data Carrier requires both AIDC andirect d HRI Not addressed Interfere with the safety or performance of the device Not technologically feasible Two years after label compliance date 25 Medtronic Confidential

26 INDIVIDUAL REGION IMPLEMENTATIONS

27 BRAZIL ANVISA UDI Public Consultation of 2017 Resolution has the objective of instituting the mandatory inclusion of a standard bar code of UDI / IMDRF on cardiological stents, hip and knee implants. Bar code to include Device Identifier (DI) and Expiry Date and Lot or Serial Number Production Identifier (PI) on the traceability label of the device package. 27 Medtronic Confidential

28 CHINA FDA UDI REGULATION Draft Rule March 2018 Accepts International Coding and reserves right for National Code Bar Code - Linear, 2 Dimensional, RFID (must have bar code back-up) Device Identifier Production Identifier Lot or Serial Number Production date Expiry date All package levels Direct Marking for reusable devices 28 Medtronic Confidential

29 TAIWAN FDA UDI Issuing Agencies / Entities - GS1, HIBCC, ICCBBA Bar Code - Linear, 2 Dimensional, also accepts RFID Device Identifier Production Identifier Lot or Serial Number Production date Expiry date All package levels Direct Marking for reusable devices requiring reprocessing between use - Mandatory Medtronic Confidential

30 SAUDI ARABIA SFDA UDI Regulation Issuing Agencies / Entities - GS1, HIBCC, ICCBBA Bar Code - Linear, 2 Dimensional, also accepts RFID Device Identifier Production Identifier Lot or Serial Number Production date Expiry date All package levels Direct Marking for reusable devices requiring reprocessing between use - Begin Enforcement Medtronic Confidential

31 SOUTH KOREA MFDS UDI The Ministry of Food and Drug Safety will introduce the UDI system, which will manage all information from production to distribution and final use of medical devices, in 2019 Project has phase approach starting in 2017 Device Identifier Production Identifier 31 Medtronic Confidential

32 ENGLAND NATIONAL HEALTH SERVICE (NHS) eprocurement Strategy Issuing Agencies / Entities - GS1 Bar Code - Linear, 2 Dimensional, also accepts RFID Device Identifier Production Identifier Lot or Serial Number Production date Expiry date Implementation Medtronic Confidential 32

33 TURKEY MOH & SGK TRACEABILITY PROGRAM Registration and Tracking System Issuing Agencies / Entities - GS1 & HIBCC Bar Code - Linear & 2 Dimensional Device Identifier Production Identifier Lot or Serial Number Expiry date All package levels - Enforcement since Medtronic Confidential

34 ARGENTINA ANMAT TRACEABILITY PROJECT Issuing Agency / Entity - GS1 Bar Code - Linear, 2 Dimensional, also accepts RFID Device Identifier Production Identifier Lot Serial Number Expiry date Enforcement February Defibrillators/cardioverters, electric stimulators for cochlear hearing, intraocular lenses, cardiac pacemaker, breast internal prosthesis; Enforcement August Vascular coronary stent, hip prosthesis, and spine prosthesis 34 Medtronic Confidential

35 JAPAN - MINISTRY OF HEALTH, LABOUR AND WELFARE (MHLW) Issuing Agency / Entity - GS1 Bar Code - Linear & 2 Dimensional Device Identifier Production Identifier Lot or Serial Number (not required for consumable supplies) Expiry date (not required for consumable supplies) All package levels - Enforcement since JFMDA Voluntary Guidelines in place since Medtronic Confidential

36 ANDALUSIAN MINISTRY OF PUBLIC HEALTH Issuing Agency / Entity - GS1 Bar Code - Linear & 2 Dimensional Device Identifier Production Identifier Lot or Serial Number Expiry date All package levels - Enforcement since Medtronic Confidential

37 Jackie Rae Elkin Global Process Owner - Standard Product Identification Corporate Regulatory Operations Medt ronic 710 Medtronic Parkway, LS330 Minneapolis, MN, USA Office: Mobile: Fax: jackie.elkin@medtronic.com medtronic.com Facebook LinkedIn Twitter YouTube LET S TAKE HEALTHCARE FURTHER, TOGETHER 37 Medtronic Confidential

38 Tom Jones Unique Device Identification (UDI) Program Director Johnson & Johnson GS

39 Benefits of UDI Harmonization Impact to Patients and Supply Chain Stakeholders Tom Jones UDI Program Director, Supply Chain Visibility Johnson & Johnson Supply Chain April 10, 2018

40 Johnson & Johnson Global science & technology company focused solely on healthcare More than 275 operating companies in 60 countries Selling products in more than 175 countries Approximately 128,000 employees worldwide SUBGROUP NAME: REGION AND/OR PROJRCT Confidential Month 00,

41 Johnson & Johnson Portfolio Consumer Baby Care Body Care Facial Skin Care Sun Care Feminine Personal Care Allergy Care Compromised Skin Care Cough and Cold Care Digestive Health Oral Care Pain Care Medical Devices Wound Closure & Surgical Devices Minimally Invasive Surgery Joint Replacement Sterilization Eye Health Diabetes Care Pharmaceuticals Oncology Infectious Diseases & Vaccines Immunology Cardiovascular & Metabolism Neuroscience & Pain Pulmonary Hypertension SUBGROUP NAME: REGION AND/OR PROJRCT Confidential Month 00,

42 SUBGROUP NAME: REGION AND/OR PROJRCT Confidential Month 00,

43 Presentation Overview Common regulatory components UDI has evolved into a global requirement Key challenges for global alignment Benefits of global alignment We ll discuss the challenges and opportunities with gaining alignment across the global UDI requirements SUBGROUP NAME: REGION AND/OR PROJRCT Confidential Month 00,

44 Elements of Harmonization Common components of UDI Regulations Eudamed Data Repositories Label Requirements Direct Marking These three components are commonly found in the published and draft UDI SUBGROUP NAME: REGION AND/OR PROJRCT Confidential Month 00, 0000 regulations, representing key opportunities for harmonization. 4 4

45 UDI Benefits Patient benefits before, during, and after their surgical procedure Pre- Surgery Authentication Identify counterfeits and ensure only genuine products are used Product Availability Improve supply chain efficiencies During Surgery Safety Only appropriate devices are used for the procedure Post- Surgery Knowledge Accurate identification of devices for performance analysis SUBGROUP NAME: REGION AND/OR PROJRCT Confidential Month 00,

46 Moving to a Global Perspective Regulations and Customer Requirements Regulations Customer Requirements US FDA UDI EU MDR Turkey (UTS) South Korea UDI India UDI China UDI Colombia? Many regulatory bodies have either published or have signaled that they will SUBGROUP NAME: REGION AND/OR PROJRCT Confidential Month 00, 0000 be publishing UDI Regulations. 4 6

47 Moving to a Global Perspective Regulations and Customer Requirements Regulations Customer Requirements UK National Health Service Qatar Hamad Medical Corporation UAE - Cleveland Clinic Many customers are requesting GS1 compliant barcodes Major customers within a given region are also driving requirements similar SUBGROUP NAME: REGION AND/OR PROJRCT Confidential Month 00, 0000 to UDI, often with requirements associated with data pools and labeling. 4 7

48 Challenges to Alignment Examples of key differences Direct marking FDA: May use plain text or barcode EU MDR: Requires 2D Barcode Human Readable 2D Barcode Data Fields: MRI Compatibility FDA: List of Values Turkey: Yes / No US FDA MR Safe MR Unsafe MR Conditional Labeling does not contain MRI Safety Information Device Class FDA: III, Implantable / Life Sustaining / Life Supporting, II, and I UK NHS: III, IIa, IIb, and I Differences in regulations require manufacturers to continually evaluate their SUBGROUP NAME: REGION AND/OR PROJRCT Confidential Month 00, 0000 strategies and can create additional transformation efforts when trying to leverage work from previously published regulations 4 8 MRI Compatibility Yes No Turkey UTS

49 Imagine Sharing data globally Opportunities with alignment in UDI regulations Countr y A Countr y B Countr y C Easier sharing of Outcomes data Adverse events / recalls Global vs. regional analysis Given compatible device identifications across regions, practitioners, researchers and manufacturers SUBGROUP NAME: may REGION AND/OR consolidate PROJRCT Confidential Month data 00, 0000 for a global, rather than a regional, view. 4 9

50 Imagine Global rather than Regional Inventory Opportunities with alignment in UDI regulations versus Region A Inventory Region B Inventory Global Inventory Region C Inventory Region D Inventory Improved response to global surgery demands Overall increase to product availability Supply Chain efficiencies Global alignment on labeling and direct marking standards will help mitigate the need for inventory SUBGROUP dedicated NAME: REGION AND/OR solely PROJRCT Confidential for Month a 00, specific 0000 region, driving improved availability for patient procedures. 5 0

51 Imagine Benefits for Patients and Hospitals Opportunities with alignment in UDI regulations Common Data Elements Common Labels and Direct Marking Patient Outcomes Analysis based on global rather than regional data Product Availability Easier to share inventory across regions if regional differences minimized Easier Identification Common definitions and data elements allow patients to search multiple repositories for additional information on their device SUBGROUP NAME: REGION AND/OR PROJRCT Confidential Month 00, Supply Chain Integrity Global awareness to counterfeits is easier if fewer label varieties exist Patient Safety Commonality in DM could reduce misinterpretations if HCP serves multiple regions

52 Volker Zeinar Global Coordinator Auto-ID Affairs B. Braun GS

53 AIDC Application GS1 STANDARDS FOR MEDICAL DEVICE IDENTIFICATION GS1 HEALTHCARE CONFERENCE, BOGOTA April, 10th 2018

54 Wide Range of Products Device Characteristics Risk Class Physical size, material Packaging Set/Kit Systems - Software Use Distribution Value $ Use Characteristics Professional Self / Family Care setting o Hospital o Non-hospital o Home Processing o Implantable o Disposable o Reusable Medical Devices are extremely diverse in size, material, processing, use and criticality! B. Braun Melsungen AG 54

55 Multi-market Labeling >20 languages on the label Country / regional groups Supply Chain efficiency Multi-market presentation of medical devices is the standard (and not the exception)! B. Braun Melsungen AG 55

56 Device Packaging Which information need to be in AIDC format on the different packaging levels? static data (GTIN) dynamic data (Exp.Date, Lot/Batch, Serial No, ) AIDC printing on the fly pre-printed codes (like in FMC) are no option What is really necessary from HC provider point of view? Differentiation between Risk Classes? (high/medium risk EHR/patient docu., prim pack = static + dyn. data) Differentiation due to the value of the device? (high/medium cost reimbursement, prim pack = only static data) Other aspects Requirements from UDI regulations are focused on patient safety aspects! Do they meet the HC provider expectations? B. Braun Melsungen AG 56

57 Production Environment Disposables 1 head (moving) 4 heads (fix) Positioning cutting Print on the fly (speed) print equipm. print head width/fixed/moving sterilization B. Braun Melsungen AG 57

58 Data Carriers Preferences on data carriers? o Past / Current linear BC (in particular on second./tertiary pack) o Current / Trend 2D code (GS1 Data Matrix) o Future RFID? (+2D code as Backup) Risk to change from linear to 2D (?) Choice of data carrier to be made by manufacturers Best practice just one data carrier on the label (1 scan to capture all data) HC providers should be able o to capture all AIDC formats as established by GS1 (image scanners) o to interpret its content (data parsing) Extract from GS1 data carrier family GS1-128 concatenated GS1-128 non-concatenated GS1 Data Matrix RFID Keep in mind global Standards also have Family Members! B. Braun Melsungen AG 58

59 Technical Challenges / Limitations technical framework limited space means small carriers + high data density e.g. DM size : 6x6-10x10 mm production/packaging line speed packaging material printing technology (inkjet, thermal transfer, laser, ) only validated ink DM through the verifier camera quality issues quality verification (ISO) translucent paper impact on contrast ISO required = C ( ) 100 % AIDC marking is impossible exceptions need to be accepted! B. Braun Melsungen AG 59

60 Major components to apply GS1 AIDC Standards Manufacturer HC Provider Print Technology AIDC Quality Control Scanners Label Design Master Data (GTIN/rules) Production Order Data AIDC has to be considered during product/packaging design Master Data SW applications to support use cases AIDC application is an end-to-end process! GS1 General Specifications + Best Practice Guidelines help to design and implement a proper AIDC use case B. Braun Melsungen AG 60

61 Summary Harmonization! Simplification Acceleration B. Braun Melsungen AG 61

62 THANK YOU VERY MUCH FOR YOUR TIME Volker Zeinar Global Coordinator Auto-ID Affairs

63 And now Audience Q&A GS

64 Welcome Reception in Circo Restaurant 17:15 18:15 MEET REMARKABLE PEOPLE AN AMAZING COLOMBIAN EXPERIENCE GS